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Related Concept Videos

In Vitro Drug Dissolution: Compendial Testing Models I01:13

In Vitro Drug Dissolution: Compendial Testing Models I

Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...
Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
In Vitro Drug Dissolution: Compendial Testing Models II01:09

In Vitro Drug Dissolution: Compendial Testing Models II

Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients, maintaining...
Drug Product Performance: In Vitro–In Vivo Correlation01:20

Drug Product Performance: In Vitro–In Vivo Correlation

In pharmaceutical development, it's crucial to establish a predictive in vitro–in vivo correlation (IVIVC) for two or more formulations to gain a comprehensive understanding of release properties. IVIVC reduces the need for costly in vivo studies and facilitates the establishment of meaningful dissolution specifications with significant cost savings and decreased regulatory burden. Furthermore, a meaningful IVIVC should predict Cmax and AUC within 20%, aligning with FDA guidance while adhering...
In Vitro Drug Release Testing: Overview, Development and Validation01:10

In Vitro Drug Release Testing: Overview, Development and Validation

In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
Modified-Release Drug Delivery Systems: Bioavailability01:30

Modified-Release Drug Delivery Systems: Bioavailability

Modified-release (MR) dosage forms are designed to extend drug release over time, thereby maintaining stable plasma concentrations and reducing dosing frequency. However, their bioavailability is typically below 100% due to incomplete drug release and presystemic metabolism, and limitations in drug permeability across the gastrointestinal epithelium, all of which can restrict the fraction of the drug reaching systemic circulation. Consequently, studying the in vivo bioavailability of MR...

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Related Experiment Video

Updated: Jun 22, 2026

Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs
08:18

Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs

Published on: July 27, 2022

Generic omeprazole delayed-release capsules: in vitro performance evaluations.

Terry Moore1, Anjanette Smith, Wei Ye

  • 1Office of Testing and Research, Division of Pharmaceutical Analysis, Food and Drug Administration, St. Louis, MO 63101, USA. terry.moore@fda.hhs.gov

Drug Development and Industrial Pharmacy
|June 27, 2009
PubMed
Summary
This summary is machine-generated.

Generic omeprazole delayed-release capsules meet quality standards. In vitro dissolution testing shows no significant difference compared to the brand-name product, refuting claims of varied therapeutic effects.

Related Experiment Videos

Last Updated: Jun 22, 2026

Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs
08:18

Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs

Published on: July 27, 2022

Area of Science:

  • Pharmaceutical Sciences
  • Drug Quality Assessment

Background:

  • Following patent expiration of omeprazole delayed-release capsules, the U.S. Food and Drug Administration (FDA) approved multiple generic versions.
  • Complaints regarding a lack of therapeutic efficacy have been reported for some generic omeprazole products.

Purpose of the Study:

  • To evaluate the quality and performance of five commercially available generic omeprazole delayed-release capsules.
  • To compare the dissolution profiles of generic omeprazole capsules against established pharmacopeial standards and the reference product.

Main Methods:

  • Dissolution characteristics of generic omeprazole delayed-release capsules were assessed using United States Pharmacopeia (USP) guidelines.
  • Additional dissolution studies were performed under simulated in vivo physiological conditions to assess comparative performance.

Main Results:

  • All tested generic omeprazole delayed-release capsules successfully met the dissolution requirements set by the USP.
  • In vitro dissolution profiles of the generic omeprazole products were found to be comparable to the brand-name omeprazole product.

Conclusions:

  • Current in vitro data do not support claims of differential performance between generic omeprazole delayed-release capsules and the original brand-name product.
  • The quality and dissolution behavior of the evaluated generic omeprazole formulations align with the reference product based on pharmacopeial standards.